FDA views stem cells as drugs, why would this be any different. The fact here is this: once TCEL sells enough shares to produce $2 million in revenue or whatever the new figure may be in the next filling then and only then can they begin clinical trials. If everything goes as expected they may have documentation to submit to the FDA in 3-8 years. Dont bet on dividends for possibly 10 years, better off playing the ticks per the chart.